Drug Product

CMC Technical Operations > Services > Services Drug Substance > Drug Product
  • Lead optimization and preformulation
  • Formulation risk assessment and optimization
  • Implementation of Quality by Design (QbD)
  • Formulation ruggedness and process robustness
  • Process validation and Continuous Process Verification (CPV)
  • Outsourcing strategies
  • CRO/CMO selection and management
  • Technical writing, research, training.

Delivering Effective, High-Quality Drug Products.

CMC Techops provides complete drug product development services that translate active pharmaceutical ingredients (APIs) into effective, high-quality finished drug products. We have an integrated science, engineering, and manufacturing team applying state-of-the-art technologies and best practices from early formulation through commercial-scale production to deliver robust, scalable solutions meeting global regulatory standards.

Our Approach to Drug Product Development

That development approach is both flexible and rigid, including everything that we are doing to get an efficient and compliant drug product manufacturing. We offer solid oral dosage form, sterile injectable and complex formulation expertise, helping us provide our expertise in meeting the unique requirements of your project at each phase.

  1. Pre-Formulation Studies : To formulate your API efficiently we perform comprehensive pre-formulation studies to determine the physicochemical properties. Solubility profiling, particle size analysis, pH stability and excipient compatibility from these studies are included. Using knowledge of the characteristics of your API, we can create formulations that give maximum bioavailability with product stability. In addition, we use our pre-formulation skills to help select the best salt of the API as well as perform polymorph screening and determine which forms would best provide improved solubility, stability and performance in the final dosage form.
  1. Formulation Development : Formulation is very important to make sure the drug product delivers the desired therapeutic effect. For several dosage forms, including tablets, capsules, injectables and topicals, we develop tailored formulations. We have expertise in developing specialized techniques, including hot melt extrusion, spray drying and nanoencapsulation, to improve the solubility and bioavailability of poorly water-soluble APIs. Through Quality by Design (QbD), we identify and control critical process parameters (CPPs) and critical quality attributes (CQAs) at all stages during the formulation development process. A systematic approach allows you to formulate products that are more robust and that fit your quality and performance specifications.
  1. Process Development and Scale-Up : The focus of CMC Techops ranges from pilot-scale development and optimization to full-scale manufacturing. Closely working with the engineers, our development scientists set up the reproducible and scalable process which preserves the product quality and consistency. Using advanced process analytical technology (PAT) to monitor and control key parameters we move seamlessly from small-scale development to commercial production. Blending, granulation, compression, coating and encapsulation are our process development services for solid oral dosage forms and aseptic filling and lyophilization of parenteral products. Using modelling techniques, we use Design of Experiments (DoE) as a means to reduce cycle times and optimize processes and, ultimately, improve overall manufacturing efficiency.

Key Capabilities in Drug Product Development

  • Oral Solid Dosage Forms: We develop solid dosage forms (tablets, capsules and oral granules) with specialized equipment and expertise. We have direct compression, wet granulation, dry granulation, and coating. To achieve the desired pharmacokinetic profile we offer modified release and controlled release technologies.
  • Sterile Injectables: At Pharmaceuticals, we produce our injectable products, including liquid and lyophilized formulations, in our sterile manufacturing facilities. As an aseptic fill finish services provider, we offer vials, prefilled syringes and cartridges fill finish services adhering to the highest standards of sterility and product quality. In addition, we develop and optimize the lyophilization cycle for product stability.
  • Topical and Transdermal Formulations: Having experience in the development of topical and transdermal drug products means we understand creams, gels, ointments and transdermal patches, which deliver the right dose through the skin. In vitro release testing (IVRT) and in vitro permeation testing (IVPT) are performed to test product efficacy and skin penetration.
  • Inhalation and Nasal Products: We provide formulation development of inhalation and nasal products as drug forms for the respiratory tract (drugs administered via the respiratory tract). We perform aerodynamic particle size distribution (APSD) tests, cascade impaction analysis and other tests to optimize deposition in the lungs or nasal cavity.

Analytical Development and Validation

Outstanding analytical development is needed to make sure that drug products meet rigid quality standards. HPLC, GC and particle size analyzers available in our laboratory help in method development, validation as well as routine testing.

Why Choose CMC Techops for Drug Product Development?

  1. Broad Dosage Form Expertise:

From novel excipients to packaging innovations, we have a broad knowledge of dosage forms, and can therefore offer specific solutions tailored to the route of administration and treatment goals of your product.

  1. Customized Solutions:

There is no ‘standard method’ and we adapt the approach for your product. We design processes from formulation to fill-finish to make sure your drug product is stable, safe, and effective.

  1. Advanced Infrastructure:

In this, our state-of-the-art CGMP facilities equipped with the latest in cutting-edge equipment allow us to work on anything from simple to complex projects, providing us with flexibility and scalable capacity from small clinical trials right through to full-scale production.

  1. Commitment to Quality and Compliance:

Quality is not negotiable at CMC Techops. You can count on our rigorous quality systems, CGMP-compliant processes and global regulatory standards which assure your product meets the most stringent requirements.